Medical Device Safety and Recalls: Merit Medical Systems, Inc. Recalls the Prelude® Short Sheath Introducer - Sheath May Separate During Use

["U.S. Food & Drug Administration (FDA)" <fda@xxxxxxxxxxxxxxxxxxxxxxx>]

Title: Medical Device Safety and Recalls: Merit Medical Systems, Inc. Recalls the Prelude® Short Sheath Introducer - Sheath May Separate During Use

Merit Medical Systems Inc. is recalling the Prelude® Short Sheath Introducer due to a manufacturing defect which may cause the tip to separate from the sheath during the insertion procedure. If this occurs, the tip could enter the patient's bloodstream. This may result in prolonged procedure times, additional surgery to remove the tip from the patient, blood clots, internal tears and perforation to arteries or veins, excessive bleeding, and death.

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